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How to Develop and Manage Qualification Protocols for FDA Compliance (Hardcover)
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How to Develop and Manage Qualification Protocols for FDA Compliance (Hardcover)
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Explains in detail how to develop and manage qualification
protocols and their associated documentation for all of the
validation department functions Shows how to perform qualification
testing and establish a requalification program Describes how
various documents relate to each other and to an overall
documentation system Discusses in details key function areas, such
as Cleaning, Facilities and Utilities, Equipment, Computers and
Software, and Process Provides ready-to-use protocols and protocol
templates All current Good Manufacturing Practices (cGMP), Good
Clinical Practices (GCP), Good Laboratory Practices (GLP) and ISO
9000 standards and regulations require that validation document be
established and followed. Yet these regulations do not provide
guidelines on how to produce documentation such as qualification
protocols. How to Develop and Manage Qualification Protocols for
FDA Compliance focuses specifically on the FDA documentation
requirements, providing concrete guidance on how to develop and
manage qualification protocols and their associated documentation
to ensure your company is not at risk. Key function areas, such as
cleaning, facilities and utilities, equipment, computers and
software, and process are discussed in detail. The book contains 35
validation procedures and 30 forms that can be used to establish a
validation documentation system and provides protocol templates you
can use as your own. Numerous diagrams and graphics are used to
illustrate key points. Most importantly, this book will provides
hands-on, "been there" advice on how to: Write protocols and final
reports Develop protocol formats and style guides Establish a
documentation review and approval system Implement document control
and forms control programs Migrate your documentation system from
paper to electronic format If your responsibilities include writing
and managing qualification protocols for drug products and related
industries, here's all
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